Videolaryngoscopy Compared to Direct Laryngoscopy

Not Applicable

Completed

• Conditions: Pulmonary Aspiration of Gastric Contents
• Interventions: Device: McGrath Mac; Device: Macintosh Laryngoscope

• Registration Number: NCT04794764
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room

Detailed Description

Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-07-24
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age ≥ 18 Years
• capacity to consent
• Present written informed consent of the research participant

Exclusion Criteria

• Age <18 years
• Existing pregnancy
• Lack of consent
• inability to consent
• Difficult Airway / Defined Indications for awake intubation
• Participation in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McGrath MAC	McGrath Mac	First pass success rate using the McGrath Mac
Macintosh Laryngoscope	Macintosh Laryngoscope	First pass success rate using the Macintosh laryngoscope

Primary Outcome Measures

Name	Time	Method
First pass Intubation success rate	at intubation in 60 seconds	successful tracheal intubation at the first attempt, compared to more than one attempt

Secondary Outcome Measures

Name	Time	Method
adverse events	after 24 hours	sore throat
Cormack and Lehane Classification	< 120 seconds	after insert the device the user describe the glottis visualisation
Time to ventilation	at intubation in 120 seconds	From Insertion of the blase into the mouth until first ventilation
Overall success rate	< 120 seconds	after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
Intubation difficult score	< 120 seconds	Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation
complications	< 120 seconds	mucosal injury

Trial Locations

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany